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Completed

NCT Number: NCT01073566

Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Pacific Medical Center, San Francisco, California, United States

Loading trial locations.

About this study

The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus on intensive insulin therapy

Exclusion criteria

  • Insulin pump therapy
  • Current use of NPH or regular insulin
  • Severe hypoglycemic episodes in prior 6 months
  • Unstable cardiac disease, hepatic, or renal function

Treatment and study plan

Finesse

Device

Finesse Insulin Delivery Patch

Other names: Insulin Bolus Patch

Pen/Syringe (Usual injection device)

Device

Pen/Syringe

Other names: Insulin pen, Insulin syringe, Insulin injection device

Primary outcomes

  1. Mean Daily Blood Glucose

    Time frame: 6 weeks

    Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose

Secondary outcomes

  1. Glucose Profiles Per Day

    Time frame: 6 weeks

    Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days

  2. Insulin Delivery System Rating

    Time frame: 6 weeks

    Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.

  3. Self-reported Hypoglycemic Episodes

    Time frame: 6 weeks

    Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.

Sponsors and collaborators

Lead sponsor

Calibra Medical, Inc.

Industry

Collaborators

  • Henry Ford Health System
  • International Diabetes Center at Park Nicollet
  • Nancy Bohannon, MD, Med. Corp.
  • Northwestern University
  • University of Texas Southwestern Medical Center

Registry information

Official study title

The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 23, 2010
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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